Home NDC 61010-5500 Isopropyl Alcohol
Product NDC 61010-5500
11-digit product format 610105500
Labeler code 61010
Product ID 61010-5500_3bdedf7b-d99b-fa9e-e063-6294a90aa631
Type HUMAN OTC DRUG
Nonproprietary name Isopropyl Alcohol
Dosage form SPRAY
Route TOPICAL
Labeler Safetec of America, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-16
Substance ISOPROPYL ALCOHOL
Active strength 70 mL/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61010-5500-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61010-5500-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61010-5500-2 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61010-5500-2 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61010-5500-2 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61010-5500-2 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61010-5500-2 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61010-5500-2 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61010-5500-2 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61010-5500-2 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 61010-5500-2 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 61010-5500-2 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61010-5500-2 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 61010-5500-2 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 61010-5500-2 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61010-5500-2 I Inactivated by FDA bd6a592717d7…303034d00443…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 61010-5500-2 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 61010-5500-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61010-5500-2 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Isopropyl Alcohol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOPROPYL ALCOHOL 70 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ND2M416302 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014638 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5500-2 Isopropyl Alcohol 59.1 mL in 1 BOTTLE, SPRAY SPRAY 59.1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5500 ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20210204_89310a64-c4cc-46c6-8294-c4d28cd88118.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 102 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join antibacterial hand sanitizer gel 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 202e5c15-8749-0a76-e063-6294a90a2720 2024-08-21 Warnings Exact identifier application number: M003 Be Smart Get Prepared Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS Total Resources International, Inc eacb5138-4af8-4550-b883-5603ad96ed7d 2024-08-16 Warnings Exact identifier application number: M003 First Aid Only Povidone-Iodine Antiseptic POVIDONE-IODINE Acme United Corporation e0052ac2-4f74-32a4-e053-2995a90a94c6 2024-08-13 Warnings Exact identifier application number: M003 Keep Going Sting Relief Pad BENZOCAINE AND ISOPROPYL ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 36c11178-b70f-4355-8823-c2b72598dae5 2024-08-08 Warnings Exact identifier application number: M003 Keep Going Non Sting Cleaning Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 6b7400d5-d4b8-4b68-b048-c1917cdf3ce3 2024-08-08 Warnings Exact identifier application number: M003 Keep Going Alcohol Prep Pad ISOPROPYL ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. f67dd10c-746f-4c21-92f1-741f86218a69 2024-08-08 Warnings Exact identifier application number: M003 Sugar Cookie Sanitizer 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1efc0e9e-b4eb-d2b0-e063-6394a90a7779 2024-08-06 Warnings Exact identifier application number: M003 Lemon Lime Hand Sanitizer Spray. 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1efe7236-d7bd-2a1c-e063-6294a90a736e 2024-08-06 Warnings Exact identifier application number: M003 Maokang Medical 10 Povidone Iodine POVIDONE-IODINE Changzhou Maokang Medical Products Co., Ltd 644e92c3-3043-4a76-9845-7e0482cf9f62 2024-07-19 Warnings Exact identifier application number: M003 Dermal Wound Cleanser BENZETHONIUM CHLORIDE Smith & Nephew Medical Ltd. 18704cd5-1ecf-4e8c-9897-7e45394e68c8 2024-07-15 Warnings Exact identifier application number: M003 Novex Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 7832a0be-a8ce-4b56-a9bb-a375b97df287 2024-07-10 Warnings Exact identifier application number: M003 Callington Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 00ca48ca-893d-4a3f-ad90-119522664e08 2024-07-10 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Grape 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1c9095ad-ce19-3666-e063-6394a90ae22d 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb78ed-36f9-a7d2-e063-6394a90a6477 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb9671-1970-39f9-e063-6294a90ac079 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbc68e-2b6b-768c-e063-6294a90a643b 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbbc55-3f7d-76d1-e063-6294a90a5590 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb701f7-61c8-e5f4-e063-6294a90a0c3c 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb77267-73ad-efd2-e063-6294a90a43f7 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb7d6ca-ef7e-5225-e063-6294a90aa692 2024-07-08 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61010-5500-2 61010550002 59.1 mL in 1 BOTTLE, SPRAY (61010-5500-2) 59.1 ml 2012-02-16 0000-00-00 No No Current